1. Product registrations / Submissions
-Actively leads product registrations by preparing/ requesting documentation needed for complex filings
-Employs project management skills to monitor activities and meet deadlines
-Prepares registration packages for routine filings
-Identifies and collects data needed
-Seeks expert advice and technical support for complex filings
-Prepares responses to deficiency letters
2. Relationships & Cross Functional team work
-Represents Regulatory CMC at relevant project meetings and communicates agreed RA position
-Monitors and communicates actual versus planned regulatory activities and timelines
-Identifies and communicates risks and issues impacting project progression
3. Affiliate Coordination
-Maintains robust working relationships with Regional Product Leads and Affiliate colleagues
4. Compliance across Life-Cycle
-Assesses and approves change requests and updates files accordingly
-Maintains awareness of legislation and current developments within specific area of business
-Works to assure products remain in compliance
5. Strategy
-Develops Regulatory CMC strategies for assigned products and projects
-Identifies, communicates, and mitigates Regulatory CMC risks
6. Process Improvement
-Identifies opportunities and suggests improvements
-Supports the development of position papers & work aids etc
7. Health Agency Interaction
-Attends Health Agency meetings as appropriate
8. Licensing Reviews
-Provides CMC Regulatory support for due diligence activities
9. Technical competency
-Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products
-Has general knowledge of global and regional regulatory requirements
-Has specialist regulatory knowledge of assigned country or product-class requirements
CORE COMPETENCIES
Adaptability
-Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks
-Regularly reviews commitment